The Impact of Continuous Glucose Monitoring Use on Sleep in Parents of Children With Type 1 Diabetes Mellitus

Type 1 Diabetes Clinical Trial

Official title:

Prospective Exploratory Study Evaluating Sleep Quality and Sleep-Wake Patterns in Parents of Children With Type 1 Diabetes Before and Several Weeks After Initiating Using RT-CGM of Their Children.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01425255
• Other study ID #: 0077-11-WOMC
• Status: Withdrawn
• Phase: N/A
• First received: August 26, 2011
• Last updated: June 18, 2016
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2011
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this prospective exploratory study is to compare sleep quality and sleep-wake patterns in parents of children with type 1 diabetes (T1D) before and several weeks after initiating using real-time continuous glucose monitoring (RT-CGM) of their children.

Description:

Few weeks before scheduled initiation of RT-CGM use of a child with T1D, the 'dominant parent' (the main caregiver during the nighttime in the family) will obtain an informed consent. This will be done during a routine visit in the diabetes clinic. The participants will complete a sleep quality questionnaire (PSQI) and instructions on care of the actigraph and how to keep complete the daily sleep diary will be given. The participants will be instructed to wear the actigraph for 7 consequences nights. Four to eight weeks after initiation of RT-CGM use, the 'dominant parent' will be asked to wear the actigraph for 7 consequences nights and to complete the sleep quality questionnaire and the daily sleep diary.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Parents of children up to 16 years old with type 1 diabetes

Exclusion Criteria:

• Either the child or parent had obstructive sleep apnea, narcolepsy, or restless legs syndrome.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Israel	E. Wolfson Medical Center	Holon

Sponsors (3)

Lead Sponsor	Collaborator
Wolfson Medical Center	Sheba Medical Center, Tel Aviv Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep quality	Actigraphy: Sleep Diary:During the weeks participants will wear the actigraph, they will be asked to rate their previous nights' sleep using a very short questionnaire.; Pittsburgh Sleep Quality Index (PSQI):	1 year	No
Secondary	Glycemic control	HbA1c level; Mean blood glucose level: Number of severe hypoglycemic episodes and diabetic ketoacidoacidosis episodes	one year	No